Devices and methods for lateral flow tests of bodily fluids

ABSTRACT

The disclosed devices for lateral flow testing may include a receptacle for receiving bodily fluids from a patient that has a predetermined fluid volume for application to one or more lateral flow test strips. A test strip holder may be positioned to receive the predetermined fluid volume of the bodily fluids from the receptacle. Various other components, devices, and methods are also disclosed.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional PatentApplication No. 63/093,011, titled “DEVICES AND METHODS FOR LATERAL FLOWTESTS OF BODILY FLUIDS,” filed 16 Oct. 2020, the entire disclosure ofwhich is incorporated herein by reference.

BACKGROUND

Peritonitis is a major cause of morbidity and mortality in peritonealdialysis (“PD”) patients globally. According to the InternationalSociety for Peritoneal Dialysis guidelines, peritonitis can be diagnosedwhen at least two of the following are present: (1) clinical featuresconsistent with peritonitis, e.g., abdominal pain and/or cloudy dialysiseffluent; (2) dialysis effluent with a white blood cell count greaterthan 100/μL or greater than 0.1×109/L (after a dwell time of at leasttwo hours), with more than 50% of the white blood counts beingpolymorphonuclear; and (3) a positive peritoneal dialysis effluentculture.

In practice, when a patient presents in the clinic with symptoms ofperitonitis, it typically takes clinicians from a couple of hours tofive days to get the results of a white blood cell count and peritonealdialysis effluent cell culture. There is also about a 10%culture-negative rate even with infections.

Once an infection diagnosis is made (without knowing the specificcausative agent(s)), the nephrologist typically initiates empiricalantibiotic therapy. Such therapy typically includes administering atleast two different broad-spectrum antibiotics which collectively covermost of the gram-positive and gram-negative bacteria, along with ananti-fungal agent to prevent secondary fungal peritonitis until thecausative agent(s) and drug susceptibility tests become available.

Lateral flow tests (also commonly referred to as “lateral flow assays”)to diagnose peritonitis or other conditions have been developed.Generally speaking, a lateral flow test for peritonitis or otherconditions are performed by placing a bodily fluid (also referred to asan “analyte”) that may contain a target substance functioning as amarker for the condition on an end of a prepared test strip, laying thetest strip on a horizontal surface, and allowing the analyte to wickacross the test strip via capillary action. As the fluid proceeds, ifthe target substance is present in the analyte, the target substancereacts with bioactive particles (also referred to as “conjugates”) andthe combined target substance and bioactive particles proceed along thestrip as the fluid proceeds. If a sufficient amount of the targetsubstance is present, the combined target substance and bioactiveparticles congregate at a test line, and an indication (e.g., a color)of the presence of the target substance appears. If there is not enough(e.g., none) of the target substance in the analyte, then the indicationdoes not appear at the test line or the indication is faint. Regardlessof whether enough of the target substance is present in the analyte, acontrol indication may appear at a control line when the fluid reachesthe control line, to indicate that the test was successfully completed.

If insufficient analyte is applied to the strip, the fluid may not reachthe control line, and no control indication will appear at the controlline. Without a control indication appearing, another test may berequired. If too much analyte is applied, the test may show a falsepositive. Additionally or alternatively, too much analyte may result inan oversaturated test strip and/or spills, which can present a hazardparticularly when the analyte is a bodily fluid.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings illustrate a number of example embodiments andare a part of the specification. Together with the followingdescription, these drawings demonstrate and explain various principlesof the present disclosure.

FIGS. 1A-1C are perspective diagrams of a device for lateral flowtesting of bodily fluids at various stages of operation, according to atleast one embodiment of the present disclosure.

FIG. 2 is a cross-sectional side view of a device for lateral flowtesting of bodily fluids, according to at least one embodiment of thepresent disclosure.

FIG. 3 is a cross-sectional side view of a device for lateral flowtesting of bodily fluids, according to at least one other embodiment ofthe present disclosure.

FIG. 4 is a cross-sectional side view of a device for lateral flowtesting of bodily fluids, according to at least one additionalembodiment of the present disclosure.

FIG. 5 is a cross-sectional side view of a device for lateral flowtesting of bodily fluids, according to at least one other embodiment ofthe present disclosure.

FIG. 6 is a flow chart illustrating a method of lateral flow testing ofbodily fluids, according to at least one embodiment of the presentdisclosure.

FIG. 7A is a perspective view of a device for lateral flow testing ofbodily fluids, according to at least one additional embodiment of thepresent disclosure. FIG. 7B is a cross-sectional side view of the deviceof FIG. 7A, taken at line A-A of FIG. 7A.

FIG. 8 is a flow chart illustrating a method of lateral flow testing ofbodily fluids, according to at least one other embodiment of the presentdisclosure.

Throughout the drawings, identical reference characters and descriptionsindicate similar, but not necessarily identical, elements. While theexample embodiments described herein are susceptible to variousmodifications and alternative forms, specific embodiments have beenshown by way of example in the drawings and will be described in detailherein. However, the example embodiments described herein are notintended to be limited to the particular forms disclosed. Rather, thepresent disclosure covers all modifications, equivalents, andalternatives falling within the scope of the appended claims.

DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS

The present disclosure is generally directed to devices and methods forlateral flow testing of bodily fluids, such as for peritonitis. In someexamples, such devices may be configured to apply a predetermined,appropriate volume of a bodily fluid on a lateral flow test strip. Forexample, the device may include a first receptacle for receiving bodilyfluids from a patient and a second receptacle configured to receivebodily fluids from the first receptacle. The first receptacle mayinclude a first, relatively larger volume, and the second receptacle mayinclude a second volume that is predetermined for application to one ormore lateral flow test strips. In an additional example, the device mayinclude a receptacle for receiving bodily fluids from a patient. Thereceptacle may have a predetermined fluid volume that is selected to beapplied to at least one lateral flow test strip. An overflow chamber maybe configured for receiving the bodily fluids in excess of thepredetermined fluid volume (e.g., that may overflow from thereceptacle).

These and other example embodiments may enable the application of anappropriate amount of bodily fluid analyte on the lateral flow teststrip(s), without additional complexity for the user. For example, thedevices of the present disclosure may receive an excess of bodily fluidswithout the user needing to precisely measure the amount applied orwithout needing to time the exposure of the test strip to the fluid. Thedevice may automatically apply the appropriate amount of the analyte tothe lateral flow test strip(s).

Features from any of the embodiments described herein may be used incombination with one another in accordance with the general principlesdescribed herein. These and other embodiments, features, and advantageswill be more fully understood upon reading the following detaileddescription in conjunction with the accompanying drawings and claims.

The following will provide, with reference to FIGS. 1A-5, 7A, and 7B,detailed descriptions of devices for lateral flow testing of bodilyfluids or other analytes, according to various embodiments of thepresent disclosure. With reference to FIGS. 6 and 8 , the following willprovide detailed descriptions of methods for lateral flow testing ofbodily fluids, according to additional embodiments of the presentdisclosure.

FIGS. 1A-1C are perspective diagrams of a device 100 for lateral flowtesting of bodily fluids at various stages of operation, according to atleast one embodiment of the present disclosure. Referring to FIG. 1A,the device 100 may include a receptacle 102 for an analyte 104 from apatient (e.g., a peritoneal dialysis patient) for testing for thepresence of a marker for a condition (e.g., peritonitis). A lateral flowtest strip 106 may be positioned for receiving the analyte 104 from thereceptacle 102 in a well portion 108. The lateral flow test strip 106may also include a conjugate pad 110, a membrane 112, a test line 114, acontrol line 116, and an absorbent pad 118.

The receptacle 102 may have a size and shape to hold a predeterminedvolume of the analyte 104 for application of an appropriate amount ofthe analyte 104 to the lateral flow test strip 106. Any analyte 104 inexcess of the predetermined volume may be kept away (e.g., divertedaway, held in another receptacle, etc.) from the lateral flow test strip106. Some suitable examples for keeping excess analyte 104 away from thelateral flow test strip 106 are described below with reference to FIGS.2-5, 7A, and 7B.

The analyte 104 may be a bodily fluid or any other fluid to be testedfor the detection and/or quantification of a target substance 120 thatmay be in the analyte 104. For example, the analyte 104 may be orinclude a sample of blood, urine, saliva, effluent from a peritonealdialysis treatment, etc., from a patient. The target substance 120 maybe a marker for a condition, such as peritonitis, a pathogen, pregnancy,etc. For example, the target substance 120 may be or include anantibody, a protein, a hormone, an antigen, bacteria, a fungus, etc.

The well portion 108 may be an adsorbent pad configured to receive theanalyte 104 and to prepare the analyte 104 (e.g., via a surfactant,buffer salt, etc.) for analysis by the lateral flow test strip 106.

The conjugate pad 110 may contain conjugates 122 (e.g., bioactiveparticles, such as antibodies) that may be reactive specifically to thetarget substance 120. For example, as shown in FIG. 1B, when the analyte104 is conveyed along the lateral flow test strip 106, particles of thetarget substance 120 may be chemically bound to the conjugates 122. Theconjugates 122 may include detectable particles, such as gold or latexmicrospheres for visual detection. Other detectable particles may alsobe used, such as fluorescent particles and/or magnetic particles. Theconjugates 122 may be maintained in a functionally stable state prior touse, such as by coating the conjugates 122 in a water-soluble material,such as sucrose. When the analyte 104 reaches the conjugates 122, thesucrose or other coating may dissolve into water of the analyte 104,exposing and chemically activating the conjugates 122 for reaction(e.g., for chemically binding) with the target substance 120.

As illustrated in FIG. 1B, the membrane 112 may be configured to furtherconvey the analyte 104 along the lateral flow test strip 106, such as bycapillary action. The membrane may include, for example, a cellulosematerial or other porous material configured to convey the analyte 104along the lateral flow test strip 106.

The test line 114 may be a region of the membrane 112 with immobilizedanti-analyte particles 124, which may be selected to react withparticles of the target substance 120 that have been bound to theconjugates 122. As illustrated in FIG. 1C, the bound target substance120 and conjugates 122 may react with the anti-analyte particles 124 andmay congregate along the test line 114. When the target substance 120 ispresent in the analyte 104 in sufficient quantities, a detectable signalmay be produced along the test line 114. For example, a visible color(e.g., from colored particles of the conjugates 122), fluorescent line,magnetic line, etc., may appear along the test line 114 to indicate thata sufficient quantity of the target substance 120 is present in theanalyte 104. If there is insufficient (e.g., no) target substance 120 inthe analyte 104, then the conjugates 122 may be conveyed past the testline 114, since the anti-analyte particles 124 may be non-reactive withthe conjugates 122 lacking the target substance 120.

The control line 116 may be a region of the membrane 112 withimmobilized anti-conjugate particles 126, which may be selected to reactwith the conjugates 122. As illustrated in FIG. 1C, the conjugates 122may react with the anti-conjugate particles 126 and may congregate alongthe control line 116. This may provide an indication that the lateralflow test strip 106 has successfully conveyed the analyte 104 across thetest line 114, regardless of whether there is enough of the targetsubstance 120 in the analyte 104 to form a positive indication on thetest line 114. Thus, after the control line 116 indicates that the testhas been completed, the test line 114 may be analyzed for a positive ornegative result.

Any additional analyte 104 may be conveyed past the control line 116 tothe absorbent pad 118. For example, the absorbent pad 118 may be asponge or other porous material configured to soak up and containadditional analyte 104.

By way of example and not limitation, various lateral flow testingconcepts will next be described. These lateral flow testing concepts maybe combined with the device 100 and related concepts as described above.Other concepts known to those skilled in the art of lateral flow testingmay also be used.

The antigen indicative of an inflammatory response in the peritoneum maybe neutrophil gelatinase-associated lipocalin, interleukin 1,interleukin 6, interleukin 8, tumor necrosis factor α, procalcitonin,and/or C-reactive protein. Lipoteichoic acid is an antigen indicative ofthe presence of gram-positive bacteria. Lipopolysaccharide is an antigenindicative of the presence of gram-negative bacteria. β-glucan is anantigen indicative of the presence of a fungus. For diagnosingperitonitis, the pathogen may be at least one bacterium and/or fungus.

In some embodiments, the conjugates 122 may include a binding moleculethat specifically binds an antigen indicative of the presence of aspecific pathogen species. For use with a peritoneal dialysis effluent,the specific pathogen may be Staphylococcus aureus, Pseudomonas sp.,Staphylococcus epidermidis, Staphylococcus haemolyticus, Candida sp.,Escherichia coli, vancomycin-resistant enterococci, or combinationsthereof.

In some examples, the lateral flow test strip 106 may include a bufferthat specifically elutes antigen(s), such as in the well portion 108 ofthe lateral flow test strip 106. The buffer composition may be chosen toselectively stabilize the antigen and/or antigen-antibody complex,maintain pH, and/or maintain or disrupt structure or binding of theantigen-antibody complex.

In certain embodiments, the device 100 may be used to diagnoseperitonitis in a patient by detecting, in a peritoneal dialysis effluentanalyte, an antigen indicative of an inflammatory response having beenlaunched in the peritoneum, detecting an antigen indicative of thepresence of a gram-positive bacteria, detecting an antigen indicative ofthe presence of a gram-negative bacteria, and/or detecting an antigenindicative of the presence of a fungus.

In some embodiment, the analyte 104 may include a peritoneal dialysiseffluent that is taken directly from the patient and applied to thedevice 100, or the peritoneal dialysis effluent may be concentrated,filtered, and/or enriched prior to application to the device 100. Incertain embodiments, enrichment may be by, for example, placing theperitoneal dialysis effluent sample into a conical tube, followed bycentrifugation of the sample, and treatment with, e.g., a lysis buffer,extraction buffer, and/or neutralization buffer. Enrichment of aperitoneal dialysis effluent sample for antigens may also be by use ofan ultrafiltration (“UF”) membrane (e.g., molecular weight cutoff29,000). In another embodiment, a syringe may be used to pass/push theperitoneal dialysis effluent sample through a UF membrane instead ofusing a centrifuge.

Such diagnostic methods can be used to treat peritonitis in the patientby first diagnosing the patient as having peritonitis and thenadministering an appropriate antibiotic to the subject to treat theperitonitis in view of the diagnosis.

The concepts discussed above with reference to FIGS. 1A-1C may beemployed in conjunction with any of the examples discussed below withreference to FIGS. 2-8 .

FIG. 2 is a cross-sectional side view of a device 200 for lateral flowtesting of bodily fluids, according to at least one embodiment of thepresent disclosure. The device 200 may include a first receptacle 202for receiving bodily fluids from a patient and a second receptacle 204positioned for receiving a portion of the bodily fluids from the firstreceptacle 202. A test strip holder 206 may be positioned under thesecond receptacle 204 to receive the bodily fluids from the secondreceptacle 204.

The first receptacle 202 may have a first fluid volume, which may belarger than is needed to perform a successful lateral flow test. Thesecond receptacle 204 may have a predetermined second fluid volume thatis selected to be applied to at least one lateral flow test strip 208inserted in the test strip holder 206. For example, the second fluidvolume may be selected to apply a sufficient amount of the bodily fluidsto the at least one lateral flow test strip 208 for a complete andsuccessful test, but not so much that the lateral flow test strip(s) 208become oversaturated.

In some examples, relational terms, such as “first,” “second,” “upper,”“below,” etc., may be used for clarity and convenience in understandingthe disclosure and accompanying drawings and may not necessarily connoteor depend on any specific preference, orientation, or order, exceptwhere the context clearly indicates otherwise.

Referring again to FIG. 2 , the device 200 may also include a transfermechanism 210 to move the bodily fluid from the second receptacle 204 tothe test strip holder 206 and ultimately to the at least one lateralflow test strip 208. In the example shown in FIG. 2 , the transfermechanism 210 may include a rotating piston 212 that may be configuredto rotate the second receptacle 204 from a first position (shown in FIG.2 in solid lines) for receiving the bodily fluid from the firstreceptacle 202 to a second position (shown in FIG. 2 in dashed lines)for transferring (e.g., via gravity) the bodily fluid from the secondreceptacle 204 to the test strip holder 206. The rotating piston 212 maybe biased (e.g., spring-biased) to the first position, such as to avoidinadvertent spilling of bodily fluids through the second receptacle 204and test strip holder 206. In some embodiments, the rotating piston 212may include a knob 214 to enable a user to grasp and rotate the rotatingpiston 212 into the second position after the bodily fluids arepositioned in the first receptacle 202 and allowed to flow into thesecond receptacle 204.

In some embodiments, the first receptacle 204 may include a lid 216 forcovering the first receptacle 204. The lid 216 may be configured toprovide a fluid-tight seal (e.g., via an O-ring and a clasp 218), whichmay reduce or eliminate a chance of spilling the bodily fluids withinthe first receptacle 204 when the lid 216 is closed.

In some examples, the test strip holder 206 may be removable andreplaceable relative to the first receptacle 202 and second receptacle204. For example, the test strip holder 206 may be used with the firstreceptacle 202 and second receptacle 204 to test bodily fluidspositioned within the first receptacle 202, and then the test stripholder 206 with its lateral flow test strip(s) 208 may be decoupled fromthe first receptacle 202 and second receptacle 204. A replacement teststrip holder 206 with one or more unused lateral flow test strip(s) 208may be coupled to the first receptacle 202 and second receptacle 204 torun another test on the bodily fluids within the first receptacle 202.Thus, multiple tests may be sequentially performed on the bodily fluidswithin the first receptacle 202, without the need for obtaining a newsample from the patient for each test.

In operation, a user may place bodily fluids to be tested within thefirst receptacle 202 and the lid 216 may be closed. The lateral flowtest strip(s) 208 that are configured to detect one or more targetsubstances may be positioned at least partially within the test stripholder 206. A portion of the bodily fluids may be allowed flow into thesecond receptacle 204. The user may rotate the knob 214 to transfer thepredetermined second volume of the bodily fluids from the secondreceptacle 204 to the lateral flow test strip(s) 208. The bodily fluidsmay be conveyed along the lateral flow test strip(s) 208 and tested forthe presence and/or quantity of the target substance(s), as describedabove with reference to FIGS. 1A-1C. After a given time (depending onthe lateral flow test strip(s) 208 used), the lateral flow test strip(s)208 may provide an indication of the presence and/or quantity of thetarget substance(s) in the bodily fluids. After the results of the testare obtained, the device 200, including any excess bodily fluids thatmay remain within the first receptacle 202, may be discarded, such as inan appropriate biohazard waste container.

FIG. 3 is a cross-sectional side view of a device 300 for lateral flowtesting of bodily fluids, according to at least one other embodiment ofthe present disclosure. The device 300 may be similar to the device 200described above with reference to FIG. 2 . For example, the device 300may include a first receptacle 302 having a first fluid volume, a secondreceptacle 304 having a predetermined second fluid volume forapplication to one or more lateral flow test strips 308, a test stripholder 306 for holding the lateral flow test strip(s) 308, and atransfer mechanism 310 for transferring the second fluid volume of thebodily fluids from the second receptacle 304 to the lateral flow teststrip(s) 308 in the test strip holder 306. The first receptacle 302 mayinclude a lid 316, such as to avoid spills of the bodily fluids from thefirst receptacle 302.

As shown in the example illustrated in FIG. 3 , the transfer mechanism310 may include a syringe 320 positioned and configured to withdraw thesecond fluid volume of the bodily fluids from the first receptacle 302.The second receptacle 304 may be defined by an internal volume of thesyringe 320 when a plunger of the syringe 320 is fully withdrawn. Afirst one-way channel 322 (e.g., a first check valve) may be positionedbetween the first receptacle 302 and the second receptacle 304. Thefirst one-way channel 322 may be configured to let fluid flow from thefirst receptacle 302 into the second receptacle 304, but may inhibit(e.g., prevent) the flow of fluid from the second receptacle 304 backinto the first receptacle 304. A second one-way channel 324 (e.g., asecond check valve) may be positioned between the second receptacle 304and the test strip holder 306. The second one-way channel 324 may beconfigured to let fluid flow from the second receptacle 304 into thetest strip holder 306, but may inhibit (e.g., prevent) the flow of fluidfrom the test strip holder 306 into the second receptacle 304. Thesyringe 320 may include a knob 326 for a user to grasp the syringe 320to operate the device 300.

In additional embodiments, the syringe 320 may be mounted to a pivot328. The second receptacle 304 may be in fluid communication with thefirst receptacle 302 when the syringe 320 and pivot 328 are in a firstposition (shown in FIG. 3 ). The syringe 320 may be rotated about thepivot 328 (e.g., in a counterclockwise direction from the perspective ofFIG. 3 ) to orient the syringe 320 such that the second receptacle 304is in fluid communication with the test strip holder 306.

In operation, a user may place bodily fluids to be tested within thefirst receptacle 302 and the lid 316 may be closed. The lateral flowtest strip(s) 308 that are configured to detect one or more targetsubstances may be positioned at least partially within the test stripholder 306. The user may grasp and pull the knob 326 to draw the secondfluid volume of the bodily fluids with the syringe 320 from the firstreceptacle 302 through the first one-way channel 322 and into the secondreceptacle 304. In embodiments in which the syringe 320 is mounted tothe pivot 328, the user may rotate the syringe 320 using the pivot fromthe first position to the second position. Whether or not the pivot 328is present, the user may then push on the knob 326 to force the secondfluid volume of the bodily fluids from the second receptacle 304 intothe test strip holder 306 and ultimately onto the lateral flow teststrip(s) 308. The bodily fluids may be tested for the presence and/orquantity of the target substance(s), as described above with referenceto FIGS. 1A-1C. After a given time (depending on the lateral flow teststrip(s) 308 used), the lateral flow test strip(s) 308 may provide anindication of the presence and/or quantity of the target substance(s) inthe bodily fluids. After the results of the test are obtained, thedevice 300, including any excess bodily fluids that may remain withinthe first receptacle 302, may be discarded, such as in an appropriatebiohazard waste container.

FIG. 4 is a cross-sectional side view of a device 400 for lateral flowtesting of bodily fluids, according to at least one additionalembodiment of the present disclosure. The device 400 may be similar tothe device 200 described above with reference to FIG. 2 . For example,the device 400 may include a first receptacle 402 having a first fluidvolume, a second receptacle 404 having a predetermined second fluidvolume for application to one or more lateral flow test strips 408, atest strip holder 406 for holding the lateral flow test strip(s) 408,and a transfer mechanism 410 for transferring the second fluid volume ofthe bodily fluids from the second receptacle 404 to the lateral flowtest strip(s) 408 in the test strip holder 406. The first receptacle 402may include a lid 416, such as to avoid spills of the bodily fluids fromthe first receptacle 402.

As shown in the example illustrated in FIG. 4 , the transfer mechanism410 may include a rotating piston 412 that may be rotated by interactionof the rotating piston 412 with a screw thread 430. In this embodiment,rotation of the rotating piston 412 may be initiated by a catalystinteracting with bodily fluids in a catalyst chamber 432. Theinteraction of the catalyst with the bodily fluids may cause thecombined catalyst and bodily fluids to expand, forcing the piston tomove linearly (e.g., to the right in the view of FIG. 4 ) and tointeract with the screw thread 430, resulting in rotation of therotating piston 412. In this example, the rotation of the rotatingpiston 412 may occur automatically, without manual manipulation by auser.

The catalyst in the catalyst chamber 432 may be any material orstructure that expands upon interaction with the bodily fluids. Forexample, the catalyst may include a foam precursor that expands uponmixing with water in the bodily fluids. In additional examples, thecatalyst may include a physical structure, such as a sponge, thatexpands upon exposure to and absorption of the bodily fluids.

In operation, the lateral flow test strip(s) 408 that are configured todetect one or more target substances may be positioned at leastpartially within the test strip holder 406. A user may place bodilyfluids to be tested within the first receptacle 402 and the lid 416 maybe closed. A portion (e.g., in the amount of the second fluid volume) ofthe bodily fluids from the first receptacle 402 may drop into the secondreceptacle 404 and another portion of the bodily fluids may drop intothe catalyst chamber 432 via gravity. As the catalyst reacts with thebodily fluids in the catalyst chamber 432 and expands, the rotatingpiston 412 may be forced to move in a linear direction (e.g., to theright in the view of FIG. 4 ). As the rotating piston 412 is forced inthe linear direction, the rotating piston 412 may press against asurface of the screw thread 430, causing the rotating piston 412 torotate. The second fluid volume of the bodily fluids may then betransferred from the second receptacle 404 into the test strip holder406 and ultimately onto the lateral flow test strip(s) 408. The bodilyfluids may be tested for the presence and/or quantity of the targetsubstance(s), as described above with reference to FIGS. 1A-1C. After agiven time (depending on the lateral flow test strip(s) 408 used), thelateral flow test strip(s) 408 may provide an indication of the presenceand/or quantity of the target substance(s) in the bodily fluids. Afterthe results of the test are obtained, the device 400, including anyexcess bodily fluids that may remain within the first receptacle 402,may be discarded, such as in an appropriate biohazard waste container.

FIG. 5 is a cross-sectional side view of a device 500 for lateral flowtesting of bodily fluids, according to at least one other embodiment ofthe present disclosure. The device 500 may be similar to the device 200described above with reference to FIG. 2 . For example, the device 500may include a first receptacle 502 having a first fluid volume, a secondreceptacle 504 having a predetermined second fluid volume forapplication to one or more lateral flow test strips 508, a test stripholder 506 for holding the lateral flow test strip(s) 508, and atransfer mechanism 510 for transferring the second fluid volume of thebodily fluids from the second receptacle 504 to the lateral flow teststrip(s) 508 in the test strip holder 306. The first receptacle 502 mayinclude a lid 516, such as to avoid spills of the bodily fluids from thefirst receptacle 502.

As shown in the example illustrated in FIG. 5 , the device 500 may beconfigured for simultaneous application of an appropriate volume of thebodily fluids to multiple lateral flow test strips 508. By way ofexample and not limitation, the transfer mechanism 510 may include anyof the transfer mechanisms 210, 310, 410 discussed above. When thetransfer mechanism 510 is used to transfer the bodily fluids from thesecond receptacle 504 to the test strip holder 506, the bodily fluidsmay optionally be diverted and applied to the multiple lateral flow teststrips 508 with a flow diverter 534. In some embodiments, the multiplelateral flow test strips 508 may be respectively configured forsimultaneous testing for multiple different respective target substancesin the bodily fluids. In this example, the second fluid volume in thesecond receptacle 504 may be selected based on the quantity of lateralflow test strips 508 to be positioned in the test strip holder 506.

FIG. 6 is a flow chart illustrating a method 600 of lateral flow testingof bodily fluids, according to at least one embodiment of the presentdisclosure. By way of example and not limitation, the method 600 may beperformed using any of the devices 100, 200, 300, 400, 500 discussedabove with reference to FIGS. 1A-5 .

At operation 610, bodily fluids may be received from a patient in afirst receptacle having a first fluid volume. Operation 610 may beperformed in a variety of ways. For example, bodily fluids including atleast one of blood, urine, saliva, and/or effluent from a peritonealdialysis treatment may be received in the first receptacle. The bodilyfluids may be introduced into the first receptacle by pouring,injection, flowing through a conduit, etc. By way of example, the bodilyfluids may be received from the patient in a clinic (e.g., doctor'soffice, testing facility, etc.), in a care facility, or in the patient'shome.

At operation 620, a portion of the bodily fluids may be passed from thefirst receptacle to a second receptacle. The second receptacle may havea predetermined second fluid volume that is selected to be applied to atleast one lateral flow test strip. Operation 620 may be performed in avariety of ways. For example, the portion of the bodily fluids may beflowed into the second receptacle by gravity or by forcing the portionof the bodily fluids into the second receptacle (e.g., by drawing in theportion of the bodily fluids with a syringe).

At operation 630, the second fluid volume of the bodily fluids in thesecond receptacle may be applied to the at least one lateral flow teststrip for lateral flow testing of the bodily fluids. Operation 630 maybe performed in a variety of ways. For example, the bodily fluids may beflowed into a test strip holder via gravity or by forcing the bodilyfluids from the second receptacle into the test strip holder (e.g., bycompressing a syringe holding the bodily fluids). In some examples, arotating piston including the second receptacle may be rotated from afirst position for receiving the bodily fluids from the first receptacleto a second position for applying the bodily fluids from the secondreceptacle into the test strip holder and ultimately onto the lateralflow test strip(s). The bodily fluids from the second receptacle may beapplied to a single lateral flow test strip or to multiple lateral flowtest strips.

FIG. 7A is a perspective view of a device 700 for lateral flow testingof bodily fluids, according to at least one additional embodiment of thepresent disclosure. FIG. 7B is a cross-sectional side view of the device700 of FIG. 7A, taken at line A-A of FIG. 7A.

The device 700 may include one or more receptacles 702 for receivingbodily fluids from a patient. Each of the receptacles 702 may have apredetermined fluid volume that may be selected to be applied to atleast one corresponding lateral flow test strip 708 in a test stripholder 706. The device 700 may also include at least one overflowchamber 734 for receiving excess bodily fluids, such as bodily fluidsthat may overflow from the receptacle 702. For example, as illustratedin FIG. 7B, the overflow chamber 734 may be positioned under the teststrip holder 706. An absorbent material 736 (e.g., a sponge, fabric,etc.) may be positioned in the overflow chamber 734 and may beconfigured to absorb and hold the excess bodily fluid within theoverflow chamber 734, such as to reduce or eliminate spilling of theexcess bodily fluid out of the overflow chamber 734.

One or more openings 738 in an upper surface 740 of the device 700 mayprovide fluid access to the overflow chamber 734. In some examples, theopening(s) 738 may be positioned at a lower elevation than an upper edgeof the receptacles 702. The upper surface 740 may slope downward fromthe upper edge of the receptacles 702 to the opening(s) 738, as shown inFIG. 7B. Thus, any excess bodily fluids may flow from the receptacles702 downward to the opening(s) 738 and ultimately into the overflowchamber 734. In some examples, the upper surface 740 may be coated witha hydrophilic coating, such that the excess bodily fluids do not stickto the upper surface 740 and readily flow toward the overflow chamber734.

In some embodiments, a transparent covering 742 may be positioned overthe test strip holder 706 to inhibit any excess bodily fluids frominadvertently reaching the lateral flow test strips 708, other thanthrough the receptacles 702 as intended. A lip 744 may extend upwardfrom the upper surface 740 along a peripheral edge of the device 700,such as to inhibit spilling any of the excess bodily fluids over theperipheral edge of the device 700.

Although four lateral flow test strips 708 are shown in the device 700of FIG. 7A, the present disclosure is not so limited. In additionalembodiments, the test strip holder 706 may be sized to accommodate one,two, three, or more than four lateral flow test strips 708. The device700 may include one, two, three, four, or more than four correspondingreceptacles 702. In additional embodiments, the device 700 may include asingle receptacle 702 for receiving bodily fluids from a patient, andthe bodily fluids may be diverted for application to one or more lateralflow test strips 708.

In operation, a user may provide bodily fluids from a patient into thereceptacle(s) 702 until the receptacle(s) 702 overflow to ensure thatthe predetermined fluid volume of the receptacle(s) 702 is full of thebodily fluids. Excess bodily fluids may flow through the opening(s) 738and into the overflow chamber 734. The bodily fluids from thereceptacle(s) 702 may be applied to the lateral flow test strip(s) 708and tested for the presence and/or quantity of the target substance(s),as described above with reference to FIGS. 1A-1C. After a given time(depending on the lateral flow test strip(s) 708 used), the lateral flowtest strip(s) 708 may provide an indication of the presence and/orquantity of the target substance(s) in the bodily fluids. After theresults of the test are obtained, the device 700, including any excessbodily fluids that may remain within the overflow chamber 734, may bediscarded, such as in an appropriate biohazard waste container.

FIG. 8 is a flow chart illustrating a method 800 of lateral flow testingof bodily fluids, according to at least one other embodiment of thepresent disclosure. By way of example and not limitation, the method 800may be performed using any of the devices 100, 700 discussed above withreference to FIGS. 1A-1C, 7A, and 7B.

At operation 810, bodily fluids from a patient may be received in areceptacle. The receptacle may have a predetermined fluid volume that isselected to be applied to at least one lateral flow test strip.Operation 810 may be performed in a variety of ways. For example, bodilyfluids including at least one of blood, urine, saliva, and/or effluentfrom a peritoneal dialysis treatment may be received in the receptacle.The bodily fluids may be introduced into the receptacle by pouring,injection, flowing through a conduit, etc. By way of example, the bodilyfluids may be received from the patient in a clinic (e.g., doctor'soffice, testing facility, etc.), in a care facility, or in the patient'shome.

At operation 820, overflow bodily fluids in excess of the predeterminedfluid volume from the receptacle may be received in an overflow chamber.Operation 820 may be performed in a variety of ways. For example, a usermay stop applying bodily fluids to the receptacle when the user observesthe bodily fluids overflowing from the receptacle. Any of the excessbodily fluids may flow into the overflow chamber through one or moreopenings in an upper surface adjacent to the receptacle. For example,the upper surface may be sloped downward from an upper edge of thereceptacle toward the opening(s). In some embodiments, an absorbentmaterial in the overflow chamber may capture and hold the excess bodilyfluids.

At operation 830, the predetermined fluid volume of the bodily fluidsfrom the receptacle may be applied to at least one lateral flow teststrip for lateral flow testing of the bodily fluids. Operation 830 maybe performed in a variety of ways. For example, gravity may cause thebodily fluids within the receptacle to be applied to the lateral flowtest strip(s). In the case of multiple lateral flow test strips, thebodily fluids may be directed to the multiple lateral flow test stripsby a flow diverter.

Accordingly, the present disclosure includes devices and methods forlateral flow testing of bodily fluids. Devices according to embodimentsof the present disclosure may enable users to confidently apply asufficient amount of bodily fluids to lateral flow test strips foreffective testing, without causing problems that may be associated withthe application of too much bodily fluids to the lateral flow teststrips. Additionally, the devices may be simple to use and relativelyinexpensive to manufacture.

The following example embodiments are also included in the presentdisclosure.

Example 1: A device for lateral flow testing of bodily fluids, which mayinclude: a first receptacle for receiving bodily fluids from a patient,the first receptacle having a first fluid volume; a second receptaclepositioned and configured to receive bodily fluids from the firstreceptacle, the second receptacle having a predetermined second fluidvolume selected to be applied to at least one lateral flow test strip;and a test strip holder shaped to receive the at least one lateral flowtest strip, wherein the test strip holder is positioned to receive thesecond fluid volume of bodily fluids from the second receptacle to testthe bodily fluids via lateral flow along the at least one lateral flowtest strip.

Example 2: The device of Example 1, wherein the test strip holder issized to receive multiple lateral flow test strips.

Example 3: The device of Example 1 or Example 2, further including atransfer mechanism to move the fluid from the second receptacle to thetest strip holder.

Example 4: The device of Example 3, wherein the transfer mechanismincludes a rotating piston configured to rotate the second receptaclefrom a first position to receive the second fluid volume of the bodilyfluids from the first receptacle to a second position to pass the secondfluid volume of the bodily fluids from the second receptacle to the teststrip holder.

Example 5: The device of Example 3 or Example 4, wherein the transfermechanism includes a syringe configured to draw the second fluid volumeof the bodily fluids from the first receptacle into the secondreceptacle and to pass the second fluid volume of the bodily fluids fromthe second receptacle to the test strip holder.

Example 6: The device of any of Examples 3 through 5, wherein thetransfer mechanism includes: a catalyst chamber in fluid communicationwith the first receptacle, the catalyst chamber configured to hold acatalyst that expands upon exposure to a sufficient volume of the bodilyfluids; a rotating piston including the second receptacle; and a screwthread configured to rotate the rotating piston upon expansion of thecatalyst into a position to pass the second fluid volume of the bodilyfluids from the second receptacle into the test strip holder.

Example 7: The device of any of Examples 1 through 6, further includinga lid for covering the first receptacle.

Example 8: The device of any of Examples 1 through 7, wherein the teststrip holder is removable and replaceable relative to the firstreceptacle and second receptacle.

Example 9: A method of lateral flow testing of bodily fluids, which mayinclude: receiving bodily fluids from a patient in a first receptaclehaving a first fluid volume; passing a portion of the bodily fluids fromthe first receptacle to a second receptacle having a predeterminedsecond fluid volume that is selected to be applied to at least onelateral flow test strip; and applying the second fluid volume of thebodily fluids from the second receptacle to the at least one lateralflow test strip for lateral flow testing of the bodily fluids.

Example 10: The method of Example 9, wherein receiving the bodily fluidsfrom the patient includes receiving at least one of the following bodilyfluids: blood; urine; saliva; or effluent from a peritoneal dialysistreatment.

Example 11: The method of Example 9 or Example 10, wherein applying thesecond fluid volume of the bodily fluids from the second receptacle tothe at least one lateral flow test strip includes rotating a pistonincluding the second receptacle from a first position to a secondposition.

Example 12: The method of any of Examples 9 through 11, wherein: passingthe portion of the bodily fluids from the first receptacle to the secondreceptacle includes drawing the portion of the bodily fluids from thefirst receptacle into the second receptacle with a syringe; and applyingthe second fluid volume of the bodily fluids from the second receptacleto the at least one lateral flow test strip includes injecting thesecond fluid volume of the bodily fluids into fluid communication withthe at least one lateral flow test strip with the syringe.

Example 13: A device for lateral flow testing of bodily fluids, whichmay include: a receptacle for receiving bodily fluids from a patient,the receptacle having a predetermined fluid volume selected to beapplied to at least one lateral flow test strip; an overflow chamber forreceiving the bodily fluids in excess of the predetermined fluid volume;and a test strip holder shaped to receive the at least one lateral flowtest strip, wherein the test strip holder is positioned to receive thepredetermined fluid volume of bodily fluids from the receptacle to testthe bodily fluids via lateral flow along the at least one lateral flowtest strip.

Example 14: The device of Example 13, wherein the overflow chamber ispositioned under the test strip holder.

Example 15: The device of Examples 13 or Example 14, wherein an uppersurface of the device slopes downward from an edge of the receptacle toan opening of the overflow chamber.

Example 16: The device of any of Examples 13 through 15, wherein theoverflow chamber includes a plurality of openings to receive the bodilyfluids that overflow from the receptacle.

Example 17: The device of Example 16, wherein the plurality of openingsare positioned along an end of the device adjacent to the receptacle andalong lateral sides of the device.

Example 18: The device of any of Examples 13 through 17, wherein thetest strip holder is sized and configured to receive a plurality oflateral flow test strips.

Example 19: The device of Example 18, wherein the receptacle comprises aplurality of receptacles corresponding to the plurality of lateral flowtest strips, wherein each receptacle of the plurality of receptacles hasa predetermined fluid volume selected to be applied to one correspondinglateral flow test strip of the plurality of lateral flow test strips.

Example 20: The device of any of Examples 13 through 19, furthercomprising an absorbent material positioned in the overflow chamber andconfigured to absorb and hold the bodily fluids in excess of thepredetermined fluid volume.

Example 21: A method of lateral flow testing of bodily fluids, which mayinclude: receiving bodily fluids from a patient in a receptacle having apredetermined fluid volume that is selected to be applied to at leastone lateral flow test strip; receiving overflow bodily fluids in excessof the predetermined fluid volume from the receptacle in an overflowchamber; and applying the predetermined fluid volume of the bodilyfluids from the receptacle to the at least one lateral flow test stripfor lateral flow testing of the bodily fluids.

Example 22: The method of Example 21, wherein receiving the overflowbodily fluids in excess of the predetermined fluid volume from thereceptacle in the overflow chamber includes flowing the overflow bodilyfluids downward from an upper edge of the receptacle to at least oneopening of the overflow chamber.

Example 23: The method of Example 21 or Example 22, wherein applying thepredetermined fluid volume of the bodily fluids from the receptacle tothe at least one lateral flow test strip includes flowing the overflowbodily fluids downward from an upper edge of the receptacle to at leastone opening of the overflow chamber.

The preceding description has been provided to enable others skilled inthe art to best utilize various aspects of the example embodimentsdisclosed herein. This example description is not intended to beexhaustive or to be limited to any precise form disclosed. Manymodifications and variations are possible without departing from thespirit and scope of the present disclosure. The embodiments disclosedherein should be considered in all respects illustrative and notrestrictive. Reference should be made to the appended claims and theirequivalents in determining the scope of the present disclosure.

Unless otherwise noted, the terms “connected to” and “coupled to” (andtheir derivatives), as used in the specification and claims, are to beconstrued as permitting both direct and indirect (i.e., via otherelements or components) connection. In addition, the terms “a” or “an,”as used in the specification and claims, are to be construed as meaning“at least one of” Finally, for ease of use, the terms “including” and“having” (and their derivatives), as used in the specification andclaims, are interchangeable with and have the same meaning as the word“comprising.”

1.-20. (canceled)
 21. A device for lateral flow testing of bodilyfluids, the device comprising: a receptacle for receiving bodily fluidsfrom a patient, the receptacle having a predetermined fluid volumeselected to be applied to at least one lateral flow test strip; anoverflow chamber for receiving the bodily fluids in excess of thepredetermined fluid volume; and a test strip holder shaped to receivethe at least one lateral flow test strip, wherein the test strip holderis positioned to receive the predetermined fluid volume of bodily fluidsfrom the receptacle to test the bodily fluids via lateral flow along theat least one lateral flow test strip.
 22. The device of claim 21,wherein the overflow chamber is positioned under the test strip holder.23. The device of claim 21, wherein the overflow chamber comprises anopening in an upper surface of the device.
 24. The device of claim 23,wherein the opening is positioned at a lower elevation relative to anupper edge of the receptacle.
 25. The device of claim 24, wherein theupper surface of the device slopes downward from the upper edge of thereceptacle to the opening of the overflow chamber.
 26. The device ofclaim 21, wherein the overflow chamber comprises a plurality of openingsin an upper surface of the device, to receive the bodily fluids thatoverflow from the receptacle.
 27. The device of claim 26, wherein theplurality of openings are positioned along an end of the device adjacentto the receptacle.
 28. The device of claim 26, wherein the plurality ofopenings are positioned along lateral sides of the device.
 29. Thedevice of claim 21, wherein the test strip holder is sized andconfigured to receive a plurality of lateral flow test strips.
 30. Thedevice of claim 29, wherein the receptacle comprises a plurality ofreceptacles corresponding to the plurality of lateral flow test strips,wherein each receptacle of the plurality of receptacles has apredetermined fluid volume selected to be applied to one correspondinglateral flow test strip of the plurality of lateral flow test strips.31. The device of claim 21, further comprising an absorbent materialpositioned in the overflow chamber and configured to absorb and hold thebodily fluids in excess of the predetermined fluid volume.
 32. Thedevice of claim 31, wherein the absorbent material is a sponge orfabric.
 33. The device of claim 21, further comprising a transparentcovering positioned over the test strip holder.
 34. The device of claim21, further comprising a lip extending upward from an upper surface ofthe device along a peripheral edge of the device.